Cervical PainNCT05582733
Effects of Cervical Spine Manipulation
A study testing Cervical spine manipulation and traction in people with Cervical Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Cervical spine manipulation and traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2019to 28 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.presence MTrps in upper trapezius
- limited side bending and rotation
- both gender
- age between 25 to 45
Who cannot join
- Malignancy, infection, trauma, bone deformities.
- Acute Disc Protrusion
- Positive VBI
- Positive Sharp purser test
- History of whiplash injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cervical Spine Manipulation on Upper Trapezius Active Versus Conventional Techniques.
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.
Read the detailed description
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.
- Conditions
- Cervical Pain
- Being tested
- Cervical spine manipulation, traction
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spine manipulationOther
hot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching
tractionOther
Hot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching.
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine manipulation | Experimental | In spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue. Receives: Other: Cervical spine manipulation; Other: traction |
| traction | Experimental | aimed to relieve pressure on the spine Receives: Other: Cervical spine manipulation; Other: traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from the baseline in Algometer values
It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.
Measured: Baseline and 3 weeks
changes from the baseline in Inclinometer values
It is a device used to measure neck ranges of motion.
Measured: Baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Aug 2019
- Primary completion30 Dec 2019
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Riphah International University
- Responsible party
- Principal investigator, Madeeha Shafiq, University of Lahore
- Investigators
- Abdul Ghafoor Sajjad, PHD*, Principal investigator, ghafoor.sajjad@riphah.edu.pk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582733
- Sponsor's protocol ID
- REC:00570
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Spine Manipulation on Upper Trapezius Active Versus Conventional Techniques.
- ClinicalTrials.gov ID
- NCT05582733
- Acronym / sponsor ID
- REC:00570
- Conditions
- Cervical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Riphah International University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.
Detailed description
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
| Arm | Type | Receives |
|---|---|---|
| Cervical spine manipulation | Experimental | Other: Cervical spine manipulation, Other: tractionIn spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue. |
| traction | Experimental | Other: Cervical spine manipulation, Other: tractionaimed to relieve pressure on the spine |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1.presence MTrps in upper trapezius
- limited side bending and rotation
- both gender
- age between 25 to 45
Key exclusion criteria (5 listed)
- Malignancy, infection, trauma, bone deformities.
- Acute Disc Protrusion
- Positive VBI
- Positive Sharp purser test
- History of whiplash injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical spine manipulationhot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching | Other | Cervical spine manipulation, traction |
| tractionHot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching. | Other | Cervical spine manipulation, traction |
Primary outcome
changes from the baseline in Algometer values
Time frame: Baseline and 3 weeks
It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.
changes from the baseline in Inclinometer values
Time frame: Baseline and 3 weeks
It is a device used to measure neck ranges of motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Ghafoor Sajjad, PHD* principal investigator
ghafoor.sajjad@riphah.edu.pk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical spine manipulation and traction in people with Cervical Pain, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from the baseline in Algometer values (time frame: Baseline and 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.